BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 2006993 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00038
    Event Type
    Death
    Date Received
    February 25, 2011
    Date of Event
    April 18, 2008
    Report Date
    April 22, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE CUSTOMER REPORTED THAT THE SAMPLE HAD BEEN DISCARDED, SO WAS NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. RESULTS: WITHOUT THE ACTUAL PRODUCT OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THERE WERE NO PROBLEMS REPORTED WITH THE PUMP. PER A HEALTH PROFESSIONAL, IT WAS STATED THAT THE PATIENT'S EXPIRATION WAS UNRELATED TO THE PUMP. IF ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT IS RECEIVED, THE FILE WILL BE REOPENED.

    Description of Event or Problem · 1

    (DRUG/DILUENT: BUPIVICAINE 0.5%). (PROCEDURE: COLON RESECTION). PATIENT PASSED AWAY AFTER BEING IN THE INTENSIVE CARE UNIT FOR A FEW DAYS. PHYSICIAN STATED, THE PATIENT WAS A VERY SICK MAN WITH A LOT OF MEDICAL ISSUES. HE DID GREAT WITH PAIN CONTROL. IT WAS STATED THAT THE PATIENT'S EXPIRATION WAS UNRELATED TO THE PUMP. THE PUMP WAS PULLED OUT EARLY SO THERE WOULD BE NO VARIABLES. FILL VOLUME 500 ML AND FLOW RATE 4 ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER ELASTOMERIC PUMP MEB I-FLOW CORPORATION PM048-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death